Snuff composition

Abstract

Use of a nicotine-cellulose combination for the preparation of a snuff composition for achievement of a fast onset of action of nicotine after application of the snuff composition to the oral cavity of a subject, wherein the composition has a high release rate so that when subjected to an in vitro dissolution test about 45% or more of the total content of nicotine is released within 30 minutes. Moreover, the invention relates to an improved snuff composition for application to the oral cavity.

The invention claimed is: 
     
       1. A pouched product comprising:
 (1) a composition comprising:
 (a) at least 45% by weight, based on the weight of the composition, of a solid nicotine-cellulose combination formed of porous cellulose having the nicotine sorbed into the pores thereof; 
 (b) a flavoring agent; 
 (c) a buffering agent; and 
 (d) one or more fillers or stabilizing agents; 
 wherein the composition comprises the nicotine in a total amount of about 1.5 mg to about 7.5 mg; and 
 
 (2) a pouch enclosing the composition. 
 
     
     
       2. The pouched product of  claim 1 , wherein the nicotine and cellulose are combined such that, when subjected to an in vitro dissolution test using UV detection, about 30% or more of the total content of the nicotine is released from the composition within 30 minutes. 
     
     
       3. The pouched product of  claim 1 , wherein the nicotine and cellulose are combined such that, when subjected to an in vitro dissolution test using UV detection, about 45% or more of the total content of the nicotine is released from the composition within 20 minutes. 
     
     
       4. The pouched product of  claim 1 , wherein the composition comprises about 80% to about 98% by weight of the nicotine-cellulose combination. 
     
     
       5. The pouched product of  claim 1 , wherein the cellulose is derived from a source selected from the group consisting of a plant, an algae, a bacterium, a fungi, and combinations thereof. 
     
     
       6. The pouched product of  claim 1 , wherein the cellulose is microcrystalline cellulose. 
     
     
       7. The pouched product of  claim 6 , wherein the microcrystalline cellulose is derived from natural cellulose. 
     
     
       8. The pouched product of  claim 1 , wherein the cellulose has a surface area of at least 0.7 m 2 /g. 
     
     
       9. The pouched product of  claim 1 , wherein the cellulose has a mean particle size of about 500 μm or less. 
     
     
       10. The pouched product of  claim 1 , wherein the nicotine is nicotine free base or a pharmaceutically acceptable salt, solvate, complex, or derivative thereof. 
     
     
       11. The pouched product of  claim 1 , wherein composition comprises about 1% to about 15% by weight, based on the weight of the composition, of the flavoring agent. 
     
     
       12. The pouched product of  claim 11 , wherein the composition comprises about 1.5% to about 8% by weight of the flavoring agent. 
     
     
       13. The pouched product of  claim 1 , wherein the composition comprises about 0.1% to about 5% by weight, based on the weight of the composition, of the buffering agent. 
     
     
       14. The pouched product of  claim 13 , wherein the composition comprises about 0.5% to about 2% by weight of the buffering agent. 
     
     
       15. The pouched product of  claim 1 , wherein the pouch is a woven material, a non-woven material, or a polymeric material. 
     
     
       16. The pouched product of  claim 1 , further comprising a sweetener. 
     
     
       17. The pouched product of  claim 16 , wherein the composition comprises about 0.01% to about 0.2% by weight, based on the weight of the composition, of the sweetener. 
     
     
       18. The pouched product of  claim 1 , further comprising an antioxidant. 
     
     
       19. The pouched product of  claim 18 , wherein the composition comprises about 0.4% to about 2.4% by weight, based on the weight of the composition, of the antioxidant. 
     
     
       20. The pouched product of  claim 1 , wherein the nicotine is in the form of a nicotine salt. 
     
     
       21. The pouched product of  claim 20 , wherein the nicotine salt is nicotine bitartrate. 
     
     
       22. The pouched product of  claim 1 , wherein the product comprises propylcellulose in addition to the solid nicotine-cellulose combination. 
     
     
       23. The pouched product of  claim 1 , wherein the product comprises microcrystalline cellulose in addition to the solid nicotine-cellulose combination. 
     
     
       24. The pouched product of  claim 1 , wherein the composition comprises maltitol. 
     
     
       25. The pouched product of  claim 1 , wherein the buffering agent comprises a carbonate. 
     
     
       26. A pouched product comprising:
 (1) a composition comprising:
 (a) at least 45% by weight, based on the weight of the composition, of a solid nicotine-cellulose combination formed of porous cellulose having nicotine bitartrate sorbed into the pores thereof; 
 (b) a flavoring agent; 
 (c) a carbonate; 
 (c) a sweetener comprising acesulfame; and 
 (d) one or more fillers or stabilizing agents comprising one or both of a cellulose and maltitol; 
 wherein the composition comprises the nicotine in a total amount of about 1.5 mg to about 7.5 mg; and 
 
 (2) a pouch enclosing the composition.